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The Konan Noncon Robo Pachy is a specular microscope and optical pachymeter, manufactured by Konan Inc. It is a noncontact ophthalmic microscope and ccamera intended for examination of the corneal endothelium, with the additional capability of measuring the corneal thickness by optical reans. Cell counting and analysis programs are included, and are indicated when it is desired to analyze the images of the cell distribution of the eye.

The Noncon Robo Pachy specular microscope and optical pachymeter is a non-contact ophthalmic microscope, optical pachymeter, and camera intended for examination of the corneal endothelium and for measurement of the thickness of the cornea. It is an improvement to the original Konan Noncon Robo, K950091.

The device permits visual inspection and photography of corneal endothelium and measurement of the corneal the thickness without any object contacting the eye. It features focusing by means of infrared techniques, and computer-assisted cell counting and cell analysis capabilities. The computer functions are also used to aid in setting up the various features of the machine and to aid in photography. Photographic images are temporarily stored in the system's memory, and are preserved in video form on magnetic tape or by using a video printer. The memory can store two endothelial cell images and two anterior segment images, which are usually those of the left and right eyes.

The provided document, a 510(k) summary for the Konan Noncon Robo Pachy, primarily focuses on establishing substantial equivalence to a predicate device rather than presenting detailed acceptance criteria and a comprehensive study report. Therefore, much of the requested information regarding specific acceptance criteria, detailed study designs, and human reader performance is not explicitly available in this document.

However, based on the information provided, here's what can be extracted and inferred:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: 100 patients for the clinical comparison of pachymetry measurements.
• Data Provenance: Not explicitly stated (e.g., country of origin, retrospective or prospective). However, the device manufacturer is Konan Inc. (Japan), and the correspondent is based in New Jersey, USA. Given the context of a 510(k) submission to the FDA, it's likely the clinical data would need to be representative of relevant populations. The study is described as comparing current measurements, suggesting a prospective or cross-sectional design.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

• The document does not mention the use of experts to establish ground truth for the test set.
• The "ground truth" for pachymetry accuracy was established by comparison to a predicate device (DGH 2000 ultrasonic pachymeter) and an accurately machined phantom, not human experts for interpretation.

4. Adjudication Method for the Test Set

• Not applicable/Not mentioned. The study involved direct measurement comparisons, not expert adjudication of classifications or diagnoses.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• No, a multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly mentioned or described. The device is for examination and measurement (specular microscopy and pachymetry), with "Cell counting and analysis programs" included. There is no indication of an AI-assisted human reader study or associated effect sizes.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

• The document implies standalone performance for the pachymetry measurement, as it's compared directly to another device and a phantom. The "Cell counting and analysis programs" are also functions of the algorithm. However, no specific details on standalone performance metrics (e.g., sensitivity, specificity for cell counting) are provided beyond the general statement that they are "indicated when it is desired to analyze the images."

7. The type of ground truth used

• For pachymetry accuracy:
  • Comparison to a legally marketed predicate device (DGH 2000 ultrasonic pachymeter).
  • Measurements on an "accurately machined phantom."
• For safety: Conformance to international safety and EMC standards.
• For software validation: Internal software validation tests.

8. The sample size for the training set

• The document does not specify a sample size for a training set. The device is primarily described as an "improvement" to an existing device (Konan Noncon Robo, K950091) with "more accurate sensors" and modified software to control the pachymeter feature. While there are "Cell counting and analysis programs," the document doesn't detail a machine learning-based approach that would typically involve a separate training set. The emphasis is on hardware and software for measurement and image acquisition/display.

9. How the ground truth for the training set was established

• Not applicable, as a discrete training set for a machine learning model is not explicitly mentioned or the focus of the submission. The "ground truth" for the device's functionality (like pachymetry) appears to be based on physical standards (phantom) and comparison to established medical devices.

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